Skip to main content
OpenTrials
Completed

NCT Number: NCT03642730

Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging

This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Caen Service de Cardiologie

Caen, 14033, France

About this study

The primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (CE-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). Such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views.

The secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All volunteers must have the ability to provide informed consent.
  • All volunteers should be affiliated to the French Social Security.
  • All volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care.

Exclusion criteria

  • Subjects with congenital heart diseases (except bicuspid aortic valve)
  • Pregnant women
  • Adults lacking decisional capacity
  • Adults placed under a legal protection regime (guardianship, curatorship, judicial protection)
  • Adults not affiliated to the French Social Security
  • Adults in emergent or critical condition
  • Adults with active pain in the intended scanning region
  • Adults with active skin disease or lesions in the intended scanning region
  • Adults with allergy/sensitivity to ultrasound gel

Treatment and study plan

TransThoracic Echocardiography imaging

Device

ultrasound scanning

Primary outcomes

  1. Echocardiography acquisition score [in %] [Operator's outcome]

    Time frame: Day 1

    Composite measurement that characterizes the echocardiography acquisition of the operator who is being assessed with respect to a 2D reference acquisition The echocardiography acquisition score is a combination of the view type score and the image quality score

  2. Time to acquisition [in seconds] [Operator's performance]

    Time frame: Day 1

    Time to acquisition [in seconds] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%

  3. Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]

    Time frame: Day 1

    Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition [Reproducibility of the probe position and orientation]

  4. Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]

    Time frame: Day 1

    Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition [Geometrical reliability of the probe position and orientation]

Secondary outcomes

  1. Left ventricular Ejection Fraction [in %] [Measurement reproducibility]

    Time frame: Day 1

    Left ventricular Ejection Fraction [in %] by Simpson's biplane method

Sponsors and collaborators

Lead sponsor

Philips Healthcare

Industry

Registry information

Acronym: EPISODE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 22, 2018
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.